Cerebral Palsy Spastic DiplegiaPhase 4NCT06583343
Effect of Botulinum Toxin on Selective Motor Control and Pain in Diplegic Cerebral Palsy
A Phase 4 study testing OnabotulinumtoxinA and Conventional Physical Therapy in people with Cerebral Palsy Spastic Diplegia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of Botulinum Neurotoxin-A (BoNT-A) injection applied to spastic muscles on pain sensation and Selective Motor Control (SMC) in cases diagnosed with diplegic spastic Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- OnabotulinumtoxinA and Conventional Physical Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2022to 25 Apr 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed with Cerebral Palsy
- Between the ages of 4-12
- GMFCS (Gross Motor Function Classification System)1-4
- Patients who have received an appropriate indication for BoNT-A injection from an experienced physiatrist
- Patients who have not had botulinum toxin administered in the last 6 months
Who cannot join
- Mental retardation
- GMFCS 5
- Have an intrathecal baclofen pump for spasticity treatment or history of soft tissue and/or bone surgery
- Underwent dorsal rhizotomy
- Have an active infection or a localized skin infection at the injection site
- Using aminoglycoside antibiotics
- Contracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital
Istanbul, Gaziosmanpaşa, 34255
About this study
Official title: Effects of Botulinum Toxin A on Selective Motor Control in Cerebral Palsy: A Simultaneous Assessment of Upper and Lower Extremities
The aim of this study is to investigate the effects of Botulinum Neurotoxin-A (BoNT-A) injection applied to spastic muscles on pain sensation and Selective Motor Control (SMC) in cases diagnosed with diplegic spastic Cerebral Palsy.
Read the detailed description
Cerebral Palsy (CP) is a non-progressive, permanent neurological disorder that occurs in the fetal or infant brain. CP, defined as a group of non-progressive movement and posture disorders, is the most common cause of neurological disability in children. The primary cause is insufficient oxygen supply to the fetus and brain asphyxia. However, other underlying factors may also be involved. Preterm birth is the most important risk factor that should be considered first.
Musculoskeletal problems mainly arise due to positive findings such as spasticity, clonus, hyperreflexia related to Upper Motor Neuron damage, and negative findings such as weakness and reduced Selective Motor Control (SMC).
Selective Motor Control (SMC) is the ability to achieve muscle activation in an appropriate pattern, in an isolated manner, to produce a voluntary movement or posture. Studies have shown that the impact of SMC on motor performance is as significant as routinely measured issues such as spasticity and contracture.
Pain is a common problem in CP, with more than half of children and adults with CP reporting pain as an issue. Assessing pain in children with CP is particularly challenging, especially in those who cannot express themselves verbally. The most common potential causes of pain include neuromuscular problems such as muscle spasms, musculoskeletal problems like hip dislocation and scoliosis, and gastrointestinal issues such as gastroesophageal reflux and constipation.
Botulinum Neurotoxin-A (BoNT-A), when applied intramuscularly, inhibits presynaptic acetylcholine (Ach) release by preventing the fusion of Ach vesicles with the plasma membrane. BoNT-A acts on the motor endplate, providing reversible chemical denervation. It is used for localized spasticity and can be applied to multiple muscles in a single session. It is generally used for spasticity starting from the age of 2. Along with rehabilitation, it aids in motor learning, promotes functional progression, and delays or prevents the development of orthopedic deformities.
The aim of our study is to investigate the effects of BoNT-A injections into spastic muscles on pain perception and SMC in patients with diplegic spastic CP.
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- OnabotulinumtoxinA, Conventional Physical Therapy
- Keywords
- Cerebral Palsy, Selective Motor Control, Botulinum Neurotoxin Injection, Spasticity, Pain
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinADrug
Also called botox
Botulinum toxin injections were administered in appropriate doses to the spastic muscles of children with cerebral palsy.
Conventional Physical TherapyOther
Conventional rehabilitation program; consisting of walking-balance exercises, range of motion exercises, stretching, and strengthening exercises, was provided for 1 hour, 5 days a week, totaling 30 sessions
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy Group | Active comparator | Conventional rehabilitation, personalized and administered under the guidance of a physiotherapist Receives: Other: Conventional Physical Therapy |
| Botulinum toxin injection group | Active comparator | Administration of botulinum toxin injection prior to the conventional rehabilitation program Receives: Drug: OnabotulinumtoxinA; Other: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCALE (Selective Control Assessment of the Lower Extremity)
SCALE; it is a scale that can be easily applied in outpatient clinic conditions, does not require any equipment. A total of 5 regions are assessed: the hip, knee, ankle, subtalar joint, and toes.
Scoring is as follows: 0 (cannot be performed), 1 (impaired SMC), and 2 (normal). If the patient performs the movement correctly within 3 seconds, without moving any other joint besides the one being evaluated and without any mirror movement, it is considered normal SMC (2 points). If there is movement in another joint, mirror movement occurs, the range of motion is less than 50% of the passive ROM (Range Of Motion), or the movement takes longer than 3 seconds, it is considered impaired SMC (1 point). If the patient cannot initiate the movement or develops flexor/extensor synergy, it is scored as unachievable (0 points).
Measured: six weeks
Boyd and Graham SMC Test
This test, developed by Boyd and Graham, aims to evaluate the Selective Motor Control (SMC) of ankle dorsiflexion. The test assesses the patient's ability to activate the muscles responsible for ankle dorsiflexion (DF). It consists of 5 items and is scored on a scale from 0 to 4.
0: No movement at all when asked to dorsiflexion the foot.
- Limited dorsiflexion achieved primarily through the use of extensor hallucis longus (EHL) and/or extensor digitorum brevis (EDB).
- Limited dorsiflexion achieved using EHL, EDB, and some tibialis anterior (TA) muscle.
- Dorsiflexion primarily using TA, but with accompanying hip and knee flexion.
- Isolated selective ankle dorsiflexion (DF) achieved through isolated TA muscle activity without hip or knee flexion.
Measured: six weeks
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a very simple and easy-to-use pain scale where patients assess the intensity of their pain between "no pain" (0 points) and "unbearable pain" (10 points). The patient rates their pain on a scale from 0 to 10:
0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
Measured: six weeks
Secondary outcomes (4)
SCUES (Selective Control of the Upper Extremity Scale)
SCUES; is a test that does not require special equipment and can be completed in less than 15 minutes. It evaluates a total of 5 joints in relation to their fundamental movement patterns: shoulder (abduction/adduction), elbow (flexion/extension), forearm (supination/pronation), wrist (flexion/extension), and fingers (grasp/release). Each joint is scored on a four-point scale:
0: No SMC (Selective Motor Control)
- Moderately reduced SMC
- Slightly reduced SMC
- Normal SMC
The patient is seated, and the evaluator first demonstrates the appropriate movement on themselves. Then, the evaluator demonstrates the movement passively on the patient and asks the patient to replicate the movement. Four key indicators of impaired SMC are:
- Presence of mirror movements
- Movement of joints other than the target joint
- Presence of trunk movements
- Inability to achieve passive end-range of motion during dynamic movement
Measured: six weeks
Functional Independence Measure for Children (WeeFIM)
It evaluates the effects of developmental problems on independence at home, school, and in the community. It guides clinicians in determining the level of daily living activities and motor skills in patients with CP, protecting them from potential secondary problems, predicting prognosis, and assessing the need for assistive devices.
Measured: six weeks
Pediatric Quality of Life Inventory (PedsQL)
It is designed to assess the quality of life in children and adolescents aged 2-18 years. There are a total of 4 subscales evaluating physical, emotional, social, and school-related functioning, with a total of 23 items. Each item is scored based on the response as 100, 75, 50, 25, or 0, then summed, and the total score is divided by the number of items to obtain the score for the corresponding subscale.
Measured: six weeks
Child and Adolescent Participation Questionnaire (CASP)
The CASP is a questionnaire that assesses the participation of patients with CP in various environments (such as home, school, and neighborhood). It consists of 4 subscales and 20 questions. Each item is scored on a scale from 0 to 4. As the total score increases, the individual's level of participation increases.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start25 Aug 2022
- Primary completion25 May 2023
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group receiving conventional physical therapy as the control group, along with another experimental group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ebru Yılmaz Yalçınkaya, Principal investigator, Gaziosmanpasa Research and Education HospitalOzan Baş, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583343
- Sponsor's protocol ID
- GaziosmanpasaTREH-FTR-OB-01
- Status last verified
- Oct 2025
- First submitted
- 1 Sep 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Botulinum Toxin A on Selective Motor Control in Cerebral Palsy: A Simultaneous Assessment of Upper and Lower Extremities
- ClinicalTrials.gov ID
- NCT06583343
- Acronym / sponsor ID
- GaziosmanpasaTREH-FTR-OB-01
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- Cerebral Palsy, Selective Motor Control, Botulinum Neurotoxin Injection, Spasticity, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effects of Botulinum Neurotoxin-A (BoNT-A) injection applied to spastic muscles on pain sensation and Selective Motor Control (SMC) in cases diagnosed with diplegic spastic Cerebral Palsy.
Detailed description
Cerebral Palsy (CP) is a non-progressive, permanent neurological disorder that occurs in the fetal or infant brain. CP, defined as a group of non-progressive movement and posture disorders, is the most common cause of neurological disability in children. The primary cause is insufficient oxygen supply to the fetus and brain asphyxia. However, other underlying factors may also be involved. Preterm birth is the most important risk factor that should be considered first.
Musculoskeletal problems mainly arise due to positive findings such as spasticity, clonus, hyperreflexia related to Upper Motor Neuron damage, and negative findings such as weakness and reduced Selective Motor Control (SMC).
Selective Motor Control (SMC) is the ability to achieve muscle activation in an appropriate pattern, in an isolated manner, to produce a voluntary movement or posture. Studies have shown that the impact of SMC on motor performance is as significant as routinely measured issues such as spasticity and contracture.
Pain is a common problem in CP, with more than half of children and adults with CP reporting pain as an issue. Assessing pain in children with CP is particularly challenging, especially in those who cannot express themselves verbally. The most common potential causes of pain include neuromuscular problems such as muscle spasms, musculoskeletal problems like hip dislocation and scoliosis, and gastrointestinal issues such as gastroesophageal reflux and constipation.
Botulinum Neurotoxin-A (BoNT-A), when applied intramuscularly, inhibits presynaptic acetylcholine (Ach) release by preventing the fusion of Ach vesicles with the plasma membrane. BoNT-A acts on the motor endplate, providing reversible chemical denervation. It is used for localized spasticity and can be applied to multiple muscles in a single session. It is generally used for spasticity starting from the age of 2. Along with rehabilitation, it aids in motor learning, promotes functional progression, and delays or prevents the development of orthopedic deformities.
The aim of our study is to investigate the effects of BoNT-A injections into spastic muscles on pain perception and SMC in patients with diplegic spastic CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group receiving conventional physical therapy as the control group, along with another experimental group
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy Group | Active comparator | Other: Conventional Physical TherapyConventional rehabilitation, personalized and administered under the guidance of a physiotherapist |
| Botulinum toxin injection group | Active comparator | Drug: OnabotulinumtoxinA, Other: Conventional Physical TherapyAdministration of botulinum toxin injection prior to the conventional rehabilitation program |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients diagnosed with Cerebral Palsy
- Between the ages of 4-12
- GMFCS (Gross Motor Function Classification System)1-4
- Patients who have received an appropriate indication for BoNT-A injection from an experienced physiatrist
- Patients who have not had botulinum toxin administered in the last 6 months
Key exclusion criteria (7 listed)
- Mental retardation
- GMFCS 5
- Have an intrathecal baclofen pump for spasticity treatment or history of soft tissue and/or bone surgery
- Underwent dorsal rhizotomy
- Have an active infection or a localized skin infection at the injection site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinAAlso: botoxBotulinum toxin injections were administered in appropriate doses to the spastic muscles of children with cerebral palsy. | Drug | Botulinum toxin injection group |
| Conventional Physical TherapyConventional rehabilitation program; consisting of walking-balance exercises, range of motion exercises, stretching, and strengthening exercises, was provided for 1 hour, 5 days a week, totaling 30 sessions | Other | Botulinum toxin injection group, Conventional Physical Therapy Group |
Primary outcome
SCALE (Selective Control Assessment of the Lower Extremity)
Time frame: six weeks
SCALE; it is a scale that can be easily applied in outpatient clinic conditions, does not require any equipment. A total of 5 regions are assessed: the hip, knee, ankle, subtalar joint, and toes. Scoring is as follows: 0 (cannot be performed), 1 (impaired SMC), and 2 (normal). If the patient performs the movement correctly within 3 seconds, without moving any other joint besides the one being evaluated and without any mirror movement, it is considered normal SMC (2 points). If there is movement in another joint, mirror movement occurs, the range of motion is less than 50% of the passive ROM (Range Of Motion), or the movement takes longer than 3 seconds, it is considered impaired SMC (1 point). If the patient cannot initiate the movement or develops flexor/extensor synergy, it is scored as unachievable (0 points).
Boyd and Graham SMC Test
Time frame: six weeks
This test, developed by Boyd and Graham, aims to evaluate the Selective Motor Control (SMC) of ankle dorsiflexion. The test assesses the patient's ability to activate the muscles responsible for ankle dorsiflexion (DF). It consists of 5 items and is scored on a scale from 0 to 4. 0: No movement at all when asked to dorsiflexion the foot. 1. Limited dorsiflexion achieved primarily through the use of extensor hallucis longus (EHL) and/or extensor digitorum brevis (EDB). 2. Limited dorsiflexion achieved using EHL, EDB, and some tibialis anterior (TA) muscle. 3. Dorsiflexion primarily using TA, but with accompanying hip and knee flexion. 4. Isolated selective ankle dorsiflexion (DF) achieved through isolated TA muscle activity without hip or knee flexion.
Visual Analog Scale (VAS)
Time frame: six weeks
The Visual Analog Scale (VAS) is a very simple and easy-to-use pain scale where patients assess the intensity of their pain between "no pain" (0 points) and "unbearable pain" (10 points). The patient rates their pain on a scale from 0 to 10: 0: No pain 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
4 secondary outcomes
SCUES (Selective Control of the Upper Extremity Scale)
Time frame: six weeks
Functional Independence Measure for Children (WeeFIM)
Time frame: six weeks
Pediatric Quality of Life Inventory (PedsQL)
Time frame: six weeks
Child and Adolescent Participation Questionnaire (CASP)
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Yılmaz Yalçınkaya principal investigator
Gaziosmanpasa Research and Education Hospital
Ozan Baş principal investigator
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OnabotulinumtoxinA and Conventional Physical Therapy in people with Cerebral Palsy Spastic Diplegia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCALE (Selective Control Assessment of the Lower Extremity) (time frame: six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.